MDR - PMCF Study for Taperloc Complete Stems

Launched by ZIMMER BIOMET · Jul 18, 2019

Keywords

ClinConnect Summary

This clinical trial, called the MDR - PMCF Study for Taperloc Complete Stems, is looking at a specific type of hip implant known as the Taperloc Complete stem. The goal is to gather information about how safe and effective this implant is for people who have had hip surgery, either for the first time or as a follow-up to a previous surgery. Researchers will collect data from patients at different time points, including 1, 3, 5, 7, and 10 years after their surgery, to see how well the implant performs and any benefits it may provide.

To participate in this study, you need to be at least 18 years old and have had hip surgery using the Taperloc Complete stem for certain conditions, such as hip arthritis or fractures. Participants should be able to understand the study and give consent to join. If you have certain health conditions, like infections or severe bone issues, you might not be eligible. If you join the study, you can expect regular follow-ups to monitor your hip health over time, contributing to important research that could help improve treatments for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 18 years of age or older and skeletally mature
• • Patient must be willing and able to sign IRB approved informed consent
• * Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
• • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• • Rheumatoid arthritis
• • Correction of functional deformity
• • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Exclusion Criteria:
• • Off-label use
• • Infection
• • Sepsis
• • Osteomyelitis
• • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• • Osteoporosis
• • Metabolic disorders which may impair bone formation
• • Osteomalacia
• • Distant foci of infections which may spread to the implant site
• • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• • Vascular insufficiency, muscular atrophy, or neuromuscular disease
• • Patient is known to be pregnant or nursing
• • Patient is a prisoner
• • Patient is a known alcohol or drug abuser
• • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent